Devices and methods for protecting a user from a sharp tip of a medical needle

ABSTRACT

There are disclosed devices and methods for protecting a user from a sharp tip of a medical needle. In an embodiment, a device includes a central body portion, a medical needle having a sharp tip, a pair of wings in attachment to the central body portion, and a hook-and-loop fastening system disposed on at least one of the wings, and configured to selectively attach the wings together with the medical needle positioned between the wings so as to protect a user from the sharp tip of the medical needle. In another embodiment, a method includes withdrawing a sharp tip of a medical needle from a patient, closing a pair of wings with the medical needle positioned between the wings, and fastening the wings together with the medical needle positioned between the wings so as to protect a user from the sharp tip of the medical needle.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/443,919, filed Feb. 27, 2017; which was a continuation ofU.S. patent application Ser. No. 15/090,040, filed Apr. 4, 2016, whichwas a divisional of U.S. Pat. No. 9,308,322, which was acontinuation-in-part of U.S. patent application Ser. No. 12/187,256,filed on Aug. 6, 2008, now U.S. Pat. No. 8,500,703, which claimedpriority from Provisional Patent Application No. 61/130,880, filed onJun. 2, 2008, the foregoing applications being incorporated herein, byreference, in their entireties.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to a device, system and method forprotecting a user from a sharp tip of a medical needle.

Description of the Related Art

Generally, Huber needles, subcutaneous needles, and other types ofmedical needles with sharp tips are inserted by medical workers formedical procedures into patients. These users typically have tocarefully maintain the sharp tip during and after removal of the medicalneedle from the patient until the medical needle is properly disposed ofin a biohazard container. As this sharp tip is contaminated with bloodor other fluids from the patient, it is considered a significant hazard.

Due to difficulties with the patient, including both physical and mentalissues, the carrier portion with the medical needle often is not handledwith the degree of care necessary by the user. In contending withvarious patient issues, a user may become injured by the sharp tip ofthe needle. FIG. 1 illustrates an example of a device 100 having a sharptip 102 at the end of a medical needle 104 between a pair of wings 106,108. Wings 106, 108 are positioned to allow placement of needle 104 intoa patient, and to assist with removal of needle 104 from the patient.However, wings 106, 108 provide little, if any, protection to a userfrom needle 104 during or after removal from the patient.

Various safety devices have been used as an attempt to ameliorate thedanger of the medical needle. However, the currently known safetydevices are generally not designed to meet clinical protocols and aredifficult to use with other devices. Current devices tend to have aprofile which will extend away from a patient's body.

SUMMARY OF THE INVENTION

In an embodiment, there is provided a device for protecting a user froma sharp tip of a medical needle, the device comprising a central bodyportion in fluid connection with a delivery tube; a medical needlehaving a first end and a second end in opposition to one another, thefirst end in fluid connection with the central body portion and thedelivery tube, and the second end of the needle extending away from thecentral body portion to a sharp tip, and a line from the first end tothe second end of the medical needle defining a longitudinal axis; apair of wings having an inner region and an outer region, the innerregion of each one of the pair of wings in attachment to the centralbody portion, the outer region of each one of the pair of wingsextending away from the central body portion, the pair of wings disposedin opposition to one another with the medical needle positionedtherebetween, and the pair of wings being selectively positionable froma first position to a second position, the first position for placingthe medical needle into a patient and delivering a medicinal fluid to asecond position, and the second position for removing the medical fromthe patient; and a mechanical fastener disposed on at least one of thepair of wings, the mechanical fastener configured to selectively attachthe pair of wings together with the medical needle positionedtherebetween so as to protect a user from the sharp tip of the medicalneedle.

In another embodiment, there is provided a device for protecting a userfrom a sharp tip of a medical needle, the device comprising a centralbody portion in fluid connection with a delivery tube; a medical needlehaving a first end and a second end in opposition to one another, thefirst end in fluid connection with the central body portion and thedelivery tube, and the second end of the needle extending away from thecentral body portion to a sharp tip, and a line from the first end tothe second end of the medical needle defining a longitudinal axis; and asleeve slideably disposed in a surrounding configuration to the centralbody portion, a sliding mechanism formed by the sleeve and the centralbody portion allowing movement of the sleeve from a first position to asecond position, the sleeve in the first position providing the medicalneedle in a configuration for insertion into a patient and delivery of amedicinal fluid in the patient, and the sleeve in the second positioncovering the medical needle so as to protect a user from the sharp tipof the medical needle.

In yet another embodiment, there is provided device for protecting auser from a sharp tip of a medical needle, the device comprising acentral body portion in fluid connection with a delivery tube; a medicalneedle having a first end and a second end in opposition to one another,the first end in fluid connection with the central body portion and thedelivery tube, and the second end of the needle extending away from thecentral body portion to a sharp tip, and a line from the first end tothe second end of the medical needle defining a longitudinal axis; and aframe member having a polygonal structure extending from the centralbody portion, the polygonal structure having a first hinged portion, asecond hinged portion, a third hinged portion, and a fourth hingedportion, the first hinged portion positioned at the central bodyportion, the second hinged portion positioned in opposition to the firsthinged portion, the third hinged portion and the fourth hinged portionpositioned, in opposition to one another, between the first hingedportion and the second hinged portion, the polygonal structure formingan opening at the second hinged portion sized for passage of the medicalneedle, the polygonal structure selectively positionable from a firstposition to a second position, the first position configured with thefirst hinged portion and the second hinged portion in an openconfiguration, and the third hinged portion and the fourth hingedportion in a closed configuration, with the medical needle extendedthrough the opening for placement into a patient and delivery of amedicinal fluid, and the second position configured with the firsthinged portion and the second hinged portion in a closed configuration,and the third hinged portion and the fourth hinged portion in an openconfiguration, with the polygonal structure surrounding the medicalneedle so as to protect a user from the sharp tip of the medical needle.

In still another embodiment, there is provided a method of protecting auser from a sharp tip of a medical needle, the method comprisingwithdrawing a sharp tip of a medical needle from a patient; closing apair of wings with the medical needle positioned therebetween; andfastening the pair of wings together with the medical needle positionedtherebetween so as to protect a user from the sharp tip of the medicalneedle.

In another embodiment, there is provided a method of protecting a userfrom a sharp tip of a medical needle, the method comprising withdrawinga sharp tip of a medical needle from a patient; and sliding a sleeveslideably disposed in a surrounding configuration to a central bodyportion from a first position providing the medical needle in aconfiguration for insertion into the patient and delivery of a medicinalfluid in the patient to a second position covering the medical needle soas to protect a user from the sharp tip of the medical needle.

In yet another embodiment, there is provided a method of protecting auser from a sharp tip of a medical needle, the method comprisingwithdrawing a sharp tip of a medical needle from a patient through anopening formed in a polygonal structure of frame member; andarticulating hinges of the polygonal structure to close the frame membersurrounding the medical needle so as to protect a user from the sharptip of the medical needle.

It is to be understood that the scope of the invention is to bedetermined by the scope of the claims as issued. Nothing in this Summaryor the Background is to be construed as requiring a feature set forthherein or that a given embodiment address issues identified in theBackground. In this regard, there are other aspects and features ofvarying embodiments. The will become apparent as the Specificationproceeds.

The construction of the invention, however, together with additionalobjects and advantages thereof will be best understood from thefollowing description of the specific embodiment when read in connectionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature of the present invention,reference should be made to the following detailed description, taken inconnection with the accompanying drawings in which like referencenumerals refer to like elements and in which:

FIG. 1 illustrates a prior art device having a needle associated withsubcutaneous fluid administration;

FIG. 2 illustrates an exemplary safety device with a mechanical fastenerof an orifice and a pin in wing portions;

FIG. 3 illustrates another safety device with a mechanical fastener ofan elongated orifice and a pin in the wing portions;

FIG. 4 illustrates a safety device with a mechanical fastener of a snapbutton in the wing portions;

FIG. 5 illustrates a safety device with a mechanical fastener of aplurality of elongated orifices and a plurality of pins in the wingportions;

FIG. 6 illustrates a safety device with a mechanical fastener having acircular shape;

FIG. 7 illustrates a safety device with a mechanical fastener having arectangular shape;

FIG. 8 illustrates a safety device with a mechanical fastener having anelliptical shape;

FIG. 9 illustrates a safety device with a mechanical fastener includinga first portion and a second portion in attachment to the wings;

FIG. 10 illustrates a safety device with a mechanical fastener having alip and a recessed portion configured to engage for attachment with oneanother, and with a groove sized to house the medical needle;

FIG. 11 illustrates a safety device, similar to the one of FIG. 10,which further includes a handle;

FIG. 12 illustrates a safety device with a mechanical fastener includinga hook-and-loop fastening system configured to engage for attachmentwith one another;

FIG. 13 illustrates a safety device with a hook-and-loop fasteningsystem configured with low profile hook material and low profile loopmaterial;

FIG. 14 illustrates a safety device with a sleeve having a slidingmechanism to selectively cover medical needle;

FIG. 15 illustrates non-DEHP tubing for use with a needle protectiondevice;

FIG. 16 illustrates a section of polypropylene lined tubing with a layerof polypropylene surrounding an inner lumen for use with a needleprotection device;

FIGS. 17 and 18 illustrate exemplary embodiments of a frame member witha polygonal structure selectively positionable to cover medical needle;

FIGS. 19-21 illustrate a frame member with a cylindrical shroud within apolygonal structure selectively positionable to cover medical needle;

FIGS. 22-25 illustrate a needle trap at the distal end of a shroud, suchas the one shown in FIGS. 19-21;

FIGS. 26 and 27 illustrate a flat spring trap with a low-profileconfiguration and designed to retain needle subsequent to use;

FIGS. 28 and 29 illustrate a trap having a very small diameter spring,which is similar to the flat spring trap shown in FIGS. 26 and 27;

FIGS. 30-32 illustrate a sliding door trap that includes a door portionand a housing portion;

FIGS. 33-36 illustrate a needle protection device that includes a needlecovering spring releasably housed in a recess within a central bodyportion; and

FIG. 37-39 illustrate further embodiments of a safety device with amechanical fastener in accordance with the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIGS. 2-15, there are provided devices for protecting auser from a sharp tip of a medical needle. These safety devices provideprotection to eliminate needle stick injuries when using needlesassociated with subcutaneous fluid administration as well as access toimplanted ports.

Subcutaneous sets needles and sets are used to infuse a pharmaceuticalproduct into the subcutaneous tissue. During the insertion and removal,the needle is exposed to users and may cause needle-stick injuries. Inaddition to subcutaneous needle, Huber needle sets (otherwise known asnon-coring needles) are used to infuse a pharmaceutical product into apreviously implanted port (which is typically made from titanium). Theport has a septum space defined between the titanium port body and anelastic membrane that covers it. Huber needles are inserted through theskin into the port.

Conventional Huber devices can pose difficulty when removing from thepatient. A clinician may need to apply a significant amount of force toremove the device. During this process, the needle may free suddenly, asa result of the force applied, and increase the risk of accidentalneedle stick injury from the exposed needle.

The safety devices described herein include, but are not limited to,subcutaneous needles and Huber needles. The safety devices improve usersafety during removal of the needle from the patient. The safety devicesdescribed herein may also be applied to other devices that have needles.

A device 200, which is shown in FIG. 2, may include a central bodyportion 202 in fluid connection with a delivery tube 204. A medicalneedle 206 has a first end 208 and a second end 210 in opposition to oneanother. First end 208 is in fluid connection with central body portion202 and delivery tube 204. Second end 210 of needle 206 may extend awayfrom central body portion 202 to a sharp tip 212. A line from first end208 to second end 210 of medical needle defines a longitudinal axis 214.

A pair of wings 216, 218 have an inner region 220 and an outer region222. Inner region 220 of each one of the pair of wings 216, 218 may beprovided in attachment to central body portion 202. Outer region 222 ofeach one of the pair of wings 216, 218 may extend away from central bodyportion 202. The pair of wings 216, 218 disposed in opposition to oneanother with the medical needle positioned therebetween, and the pair ofwings 216, 218 being selectively positionable from a first position to asecond position. The first position may be generally configured forplacing medical needle 206 into a patient and delivering a medicinalfluid. The second position may be configured for removing the medicalneedle 206 from the patient.

A mechanical fastener 224 may be disposed on at least one of pair ofwings 216, 218. Mechanical fastener 224 may be configured to selectivelyattach the pair of wings 216, 218 together with medical needle 206positioned in between wings 216, 218. This attachment of the wings 216,218 protects a user from sharp tip 212 of medical needle 206. In oneembodiment, fastener 224 may include portions 224A and 224B.

Optionally, central body portion 202 may include a handle. For example,FIG. 11 illustrates a handle 1126 extending from central body portion202.

Referring to FIG. 2, mechanical fastener 224 may include one of wings216, 218 with an orifice 224A and a pin 2248 extending from other one ofwings 216, 218. Orifice 224A and pin 224B may be configured to engagewith one another to selectively attach the pair of wings 216, 218together with medical needle 218 positioned between wings 216, 216. Thisattachment of the wings 216, 218 protects a user from sharp tip 212 ofmedical needle 206.

Orifice 224A has a diameter 226. Pin 224B also has a diameter 228. Inone embodiment, diameter 226 of orifice 224A is shorter than thediameter 228 of pin 224B. Looking at FIG. 3, there is shown a device 300having mechanical fastener 324. In one embodiment, mechanical fastenermay include portions 324A and 324B. For example, an orifice 324A isprovided with a major axis 330 and a minor axis 332. A pin 324B isprovided with a diameter 328. Major axis 330 of orifice 324A is longerthan diameter 328 of pin 324B. Minor axis 324B of orifice 324B isshorter than diameter 328 of pin 324B.

In an embodiment, a device 400 (FIG. 4) with mechanical fastener 424 mayinclude a male portion 424A and a female portion 424B. For example,mechanical fastener may be configured as a snap button 424 Male portion424A of snap button 424 may be mounted to one of wings 216, 218. Femaleportion 424B of snap button 424B may be mounted to the other one of thewings 216, 218. Male portion 424A and female portion 424B of snap button424 are configured to engage with one another to selectively attach thepair of wings 216, 218 together with the medical needle 206 positionedbetween wings 216, 218. This attachment of the wings 216, 218 protects auser from sharp tip 212 of medical needle 206.

Referring now to FIG. 5, and in an embodiment, a device 500 may includemechanical fastener 524 with female portions 524A and a male portions524B. For example, one of the wings 216, 218 forms a plurality oforifices 524A and the other one of the wings 216, 218 has a plurality ofpins 524B. The plurality of pins 524B and the plurality of orifices 524Amay be configured to engage with one another to selectively attach thepair of wings 216, 218 together with medical needle 206 positionedbetween wings 216, 218. This attachment of the wings 216, 218 protects auser from sharp tip 212 of medical needle 206.

Wings 216, 218 may have various shapes. For example, device 600 haswings 216, 218 with a circular shape (FIG. 6.) Device 700 has wings 216,218 with a rectangular shape (FIG. 7.) Device 800 has wings 216, 218with an elliptical shape (FIG. 8).

A device 900, which is shown in FIG. 9, may include a mechanicalfastener 924 with a first portion 934 in attachment to one of the wings216, 218, and a second portion 936 in attachment to the other one of thewings 216, 218. First portion 934 and second portion 936 may beconfigured to engage with one another to selectively attach the pair ofwings 216, 218 together with medical needle 206 positioned between wings214, 216. This attachment of the wings 216, 218 protects a user fromsharp tip 212 of medical needle 206.

In an embodiment, a device 1000 (FIG. 10) may include a mechanicalfastener 1024 with one or both of the wings 216, 218 forming a recessedportion 1038 adjacent a perimeter 1040. Mechanical fastener 1024 mayalso include a lip 1042 extending from at least a portion of perimeter1040 of one or both of the wings 216, 218. Recessed portion 1038 and lip1042 may be configured to engage with one another to selectively attachthe pair of wings 216, 218 together with medical needle 206 positionedbetween wings 216, 218. This attachment of the wings 216, 218 protects auser from sharp tip 212 of medical needle 206.

If desired, a device 1000 can include mechanical fasteners in additionto the mechanical fastener 1024. For example, an adhesive and/or hookand loop fastener, or other type of fastener, disclosed herein orotherwise, can be used in addition to the mechanical fastener 1024 ofthe device 1000. Referring now to FIG. 37, there is shown a device 1000′including the mechanical fastener 1024, as well as additional fasteners,such as mating hook-and-loop fastener portions 1224A and 1224B and/orpins 224B and orifices 224A, as described in connection with FIG. 2.Note that the invention is not intended to be limited only to theembodiments shown herein other variations may be provided withoutdeparting from the scope and spirit of the present invention. Forexample, in addition to the fastener 1024, more or fewer pins andorifices 224A, 224B can be used with or without hook-and-loop fasteners1224A, 1224B, without departing from the scope of the invention.Alternately, it should be understood that the device 1000′ could includethe fastener 1024 and the hook-and-loop fasteners 1224A, 1224B, and notthe pins and orifices 224A, 224B, if desired. Further, other types offasteners can be used in addition to the mechanical fastener 1024, suchas adhesive and/or snaps 424A and 424B of FIG. 4, in place of, or inaddition to, the pins and orifices 224A, 224B and/or the hook-and-loopfastening portions 1224A and 1224B, without departing from the scope ofthe present invention.

Referring now to FIGS. 10 and 37, in one embodiment, the pair of wings216, 218 may include rigid material. In another embodiment, the pair ofwings 216, 218 may include semi-rigid material. The pair of wings 216,218 of device 1000, 1000′ may be provided in various shapes including,but not limited to, circular shapes and rectangular shapes. See, forexample FIGS. 38 and 39, in which other shaped wing designs are shown.Please note that this is not meant to be limiting, as any embodiment ofthe present invention can be made with differently shaped wings(circles, ellipses, rectangles, trapezoids, etc.), including any othershape desired and/or described herein, without departing from the spiritand scope of the present invention. Additionally, as shown in FIGS.37-39, one or more types of mechanical fastener (such as pin andorifice, hook-and-loop, adhesive and/or snaps) can be used in additionto the lip and recessed portion fastener 1024, if desired.

Device 1000, 1000′ may be provided with a groove 1044 in at least one ofthe wings 216, 218. Groove 1044 may be sized for housing medical needle206 after the pair of wings 216, 218 are attached to one another. Thisattachment of the wings 216, 218 protects a user from sharp tip 212 ofmedical needle 206. In one embodiment, groove 1044 may be formed in asingle one of the wings 216, 218. In another embodiment, groove may beformed in both of the wings 216, 218.

A device 1100 (FIG. 11) provides an exemplary embodiment of handle 1126extending from central body portion 202. Any of the embodimentsdisclosed herein may include a handle extending away from central bodyportion 202 in opposition to medical needle 206 and in a direction fromsecond end 210 to first end 208 of medical needle 206.

Looking at FIG. 12, and in an embodiment, mechanical fastener 1200 mayinclude a hook-and-loop fastening system 1224 disposed on the pair ofwings 216, 218. Hook-and-loop fastening system 1124 may be configured toengage with one another to selectively attach the pair of wings 216, 218together with medical needle 206 positioned between wings 216, 218. Thisattachment of the wings 216, 218 protects a user from sharp tip 212 ofmedical needle 206.

Hook-and-loop fastening system 1224 may include a hook material 1224Adisposed on one of the wings 216, 218. A loop material 12248 may bedisposed on the other one of the wings 216, 218. Hook material 1224A andloop material 1224B may be configured to engage with one another toselectively attach the pair of wings 216, 218 together with medicalneedle 206 positioned between wings 216, 218. This attachment of thewings 216, 218 protects a user from sharp tip 212 of medical needle 206.

Referring to FIG. 13, and in one embodiment, device 1300 may providehook-and-loop fastening system 1224 with hook material 1224A having alow profile together with loop material 1224B having a low profile.

Referring back to FIG. 12, hook-and-loop fastening system 1224 may alsoinclude hook material 1224A and loop material 1224B on each of the pairof wings 216, 218. Hook material 1224A and loop material 1224B may bedisposed for engagement with one another on opposed wings 216, 218. Thisconfiguration of hook material 1224A and loop material 1224B provides adual locking configuration.

In an embodiment, hook-and-loop fastening system 1224 may include hookmaterial 1224A on one of the wings 216, 218, loop material 1224B on theother one of the pair of wings 216, 218, and adhesive material 1246within one or both of hook material 1224A and loop material 1224B.Adhesive material 1246 in hook material 1224A and loop material 1224Bmay be disposed for engagement with one another to attach the pair ofwings 216, 218 together with medical needle 206 positioned between wings216, 218. This attachment of the wings 216, 218 protects a user fromsharp tip 212 of medical needle 206.

In various embodiments, wings 216, 218 may be configured with variousmaterials and in various shapes. For example, wings 216, 218 of device1200 may include rigid material. Wings 216, 218 of device 1200 mayinclude semi-rigid material. Wings 216, 218 of device 1200 may includesoft material. Wings 216, 218 of device 1200 may include gel material.Wings 216, 218 of device 1200 may include cloth. Wings 216, 218 ofdevice 1200 may include non-woven cloth. In addition, the pair of wings216, 218 may include a combination of a rigid material, a semi-rigidmaterial, a soft material, a gel material, a cloth material, and anon-woven cloth material. Wings 216, 218 of device 1200 may have one ormore shapes, including, for example, a circular shape, a rectangularshape.

In an embodiment, adhesive material 1246 may be dynamically activated.Dynamic bonding agents may include a two component glue-primer and glueeach applied to one of the two surfaces to be bonded in which neithercomponent is active until contact with one another. In an alternativeexample, a “bubble” full of instant glue, which may have a response timeof under three seconds, may be configured to burst upon pressing wings216, 218 together.

Adhesive material 1246 may be incorporated in a gel carrier. A gelcarrier is a good way to house a bubble of the instant glue above. Gelor silicone are a very comfortable materials for patients and canoverlay hypo-allergenic double-sided adhesive tapes. This may facilitateattachment of the device to the patient's skin.

Referring now to FIG. 14, and in an embodiment, a device 1400 isprovided to protect a user from sharp tip of medical needle. Device 1400may include a central body portion 1402 in fluid connection with adelivery tube 1404.

A medical needle 1406 may be provided with a first end 1408 and a secondend 1410 in opposition to one another. First end 1408 may be in fluidconnection with central body portion 1402 and delivery tube 1404. Secondend 1410 of needle 1406 may extending away from central body portion1402 to a sharp tip 1412. A line from first end 1408 to second end 1410of medical needle 1406 defines a longitudinal axis 1414.

A sleeve 1416 may be slideably disposed in a surrounding configurationto central body portion 1402. A sliding mechanism 1418 (e.g., grooves1418) may formed by sleeve 1416 and central body portion 1402 to allowmovement of sleeve 1416 from a first position to a second position.

In the first position, sleeve 1416 may provide medical needle 1416 in aconfiguration for insertion into a patient and delivery of a medicinalfluid in the patient (i.e., needle 1406 is substantially perpendicularto delivery tube 1404.) In the second position, sleeve 1416 may covermedical needle 1406 so as to protect a user from sharp tip 1412 ofmedical needle 1406 (i.e., needle 1406 is substantially parallel todelivery tube 1404).

In one embodiment, needle safety devices may be provided non-DEHP tubing1500 (FIG. 15) or polypropylene lined tubing 1600 (FIG. 16) with a layer1602 of polypropylene surrounding an inner lumen 1604. Most needlesafety devices may be built with a non-DEHP tubing. Polypropylene is ameans to minimize chemical interaction (i.e., between the drug and theplastic, thus, minimizing the bleaching effect). Devices may be providedwith two tubing material options to minimize chemical interchange withdrug. One of these options may include non-DEHP tubing. Another optionis polyethylene lined tubing, which provides the least interaction withinfused drug.

Referring to FIGS. 17-18, and in an embodiment, a device 1700 isprovided for protecting a user from a sharp tip of a medical needle.Device 1700 includes a central body portion 1702 in fluid connectionwith a delivery tube 1704. A medical needle 1706 has a first end 1708and a second end 1710 in opposition to one another. First end 1708 maybe in fluid connection with central body portion 1702 and delivery tube1704. Second end 1710 of needle 1706 extends away from central bodyportion 1702 to a sharp tip 1712. A line from first end 1708 to secondend 1710 of medical needle 1706 defines a longitudinal axis 1714.

Device 1700 includes a frame member 1716 forming a polygonal structure1718 extending from central body portion 1702. Polygonal structure 1718has a first hinged portion 1720A, a second hinged portion 1720B, a thirdhinged portion 1720C, and a fourth hinged portion 1720D. First hingedportion 1720A and second hinged portion 1720C may be positioned atcentral body portion 1720. First hinged portion 1720A and second hingedportion 1720B may be positioned in opposition to one another. Thirdhinged portion 1720C and fourth hinged portion 1720D may be positionedin opposition to one another and extend from first hinged portion 1720Aand second hinged portion 1720B. Polygonal structure 1718 may form anopening 1722 at second hinged portion 1720B sized for passage of medicalneedle 1706.

Polygonal structure 1718 may be selectively positionable from a firstposition to a second position. First position 1718 may be configuredwith each of first hinged portion 1720A and second hinged portion 1720Bin a closed configuration, and third hinged portion 1720C and fourthhinged portion 1720D in a closed configuration. For insertion intopatient, 1720A and 1720B are typically in an open position, which allowswings 1730 to serve as the handle and device to insert the needle whilethird hinged portion 1720C and fourth hinged portion 1720D are in theclosed position with layer 1726 laying flat against mechanical fasteners1724 In this configuration, medical needle 1706 is extended throughopening 1722 for placement into a patient and delivery of a medicinalfluid. After insertion, mechanical fastener portions 1732 are laid overbase portion 1728 (mechanical fastener portions 1732 and base portion1728 may have hook-and-loop fastener portions on both sides) to securethe overall device in place. Prior to removal, fastener portions 1732are removed from base portion 1728, then the clinician's hand (left orright depending on preference) is placed over layer 1726 but not overany other layer and first hinged portion 1720A and second hinged portion1720B are moved to an open position to allow for the needle to be pulledout thus bringing third hinged portion 1720C and fourth hinged portion1720D to a closed position. Second position may be configured with firsthinged portion 1720A and second hinged portion 1720B in an openconfiguration, and third hinged portion 1720C and fourth hinged portion1720D in an open configuration. In this configuration, medical needle1706 is withdrawn through opening 1722 and polygonal structure 1718 isclosed around medical needle 1706. This surrounding configuration ofpolygonal structure 1718 around medical needle 1706 protects a user fromsharp tip 1712.

In an embodiment, one or more mechanical fasteners 1724 may be disposedon frame 1716. Mechanical fastener 1724 may be configured to selectivelyattach opposed areas of portions 1720C and 1720D to one another withmedical needle 1706 positioned between opposed ones of portion 1720A and1720B, and portion 1720C and 1720D. This surrounding configuration ofpolygonal structure 1718 around medical needle 1706 protects a user fromsharp tip 1712.

In one embodiment, one or more mechanical fasteners 1724 may include ahook-and-loop fastening system. The hook-and-loop fastening system mayinclude a hook material having a low profile as well as a loop materialhaving a low profile. In an embodiment, the hook-and-loop fasteningsystem may include a hook material and a loop material on each of theregions 1724 between third hinged portion 1720C and fourth hingedportion 1720D. The hook material and the loop material may be disposedto engage with one another so as to provide a dual lockingconfiguration.

Mechanical fastener 1724 may include an adhesive material disposed onone or more of portion 1720C and 1720D. The adhesive material may beconfigured to engage with another area of portions 1720C and 1720D ofpolygonal structure 1718 to selectively attach opposed portions 1720Cand 1720D of polygonal structure 1718 to one another with medical needle1706 positioned between opposed portions 1720A, 1720B, 1720C, and 1720D.This surrounding configuration of polygonal structure 1718 aroundmedical needle 1706 protects a user from sharp tip 1712.

In an embodiment, the adhesive material may be dynamically activated.The adhesive material may optionally be incorporated in a gel carrier.In various embodiments, mechanical fastener 1724 may include peelablecoverings containing adhesive.

Opposed portions 1720A, 1720B, 1720C, and 1720D of polygonal structure1718 may be shaped in a variety of shapes, which include, but are notlimited to a circular shape, a rectangular shape, and an ellipticalshape. Opposed portions 1720A and 1724B as well as 1720C and 1720D ofpolygonal structure 1718 may include rigid material, semi-rigidmaterial, soft material, gel material, cloth, non-woven cloth, or acombination of these materials.

In an embodiment, an adhesive layer 1726 may extend from central bodyportion 1702.

Handle 1730 may extend away from central body portion 1702 in oppositionto medical needle 1706 and in a direction from first end 1708 to secondend 1710 of medical needle 1706. Handle 1730, or any of the handlesdescribed hereinabove, facilitates the manipulation of the device duringremoval. Handle 1730 may be shaped as a tab, a loop, with flaps orwings, or as a detachable clip. Handle 1730 may include rigid material,semi-rigid material, soft material, gel material, cloth, non-wovencloth, or a combination of these materials. Handle 1730 allows the userto remove device 1700 by providing a grab portion to be pulled upwardly.Handle 1730 may include a mechanical fastener 1732 (for example,hook-and-loop material 1732) that mates with base portion 1728. In anembodiment, a mechanical fastener 1732 may extend from base 1728. Handle1730 and mechanical fastener 1732 may be used to maintain device 1700 ina relatively flat configuration, and are generally not attached to apatient. Mechanical fastener 1732 may be configured to removeably attachto a patient.

Various methods of protecting a user from a sharp tip of a medicalneedle are provided by the present invention. In one exemplaryembodiment, a method of protecting a user from a sharp tip of a medicalneedle includes withdrawing a sharp tip of a medical needle from apatient. The method further includes closing a pair of wings with themedical needle positioned between the wings. The method also includesfastening the pair of wings together with the medical needle positionedbetween the wings. This protects a user from the sharp tip of themedical needle.

In another exemplary embodiment, a method of protecting a user from asharp tip of a medical needle includes withdrawing a sharp tip of amedical needle from a patient. The method also includes sliding a sleeveslideably disposed in a surrounding configuration to a central bodyportion from a first position providing the medical needle in aconfiguration for insertion into the patient and delivery of a medicinalfluid in the patient to a second position covering the medical needle.This protects a user from the sharp tip of the medical needle.

In an embodiment, a method of protecting a user from a sharp tip of amedical needle includes withdrawing a sharp tip of a medical needle froma patient through an opening formed in a polygonal structure of framemember. The method further includes articulating hinges of the polygonalstructure to close the frame member surrounding the medical needle. Thisprotects a user from the sharp tip of the medical needle.

Most of the safety devices may be configured with a low profile andsmall foot print. A small foot-print is particularly useful when theimplanted port is a dual port that can only be accessed by two needlesets with a small footprint. Selected materials and a low profileprovide enhanced patient comfort, ease of manipulation, ease offixation, and reduced number of separate pieces to be used when thedevice is put on the patient.

A misaligned orifice may be provided in device 1700 by providing anon-concentric needle axis through orifice 1722. Needle 1706 is forcedto fit through orifice 1722 during assembly of the device. Once theneedle is pulled through orifice 1722, its axis will force it to itsnatural position and, thus, it will not be in alignment with orifice1722. In one embodiment, the orifice through which the needle goesthrough on a lower wing can be purposely misaligned (e.g., about twiceas much as the needle diameter) so that when the needle is pulled andthe double wings take a diamond shape that gradually flattens; theneedle will shift out of alignment with the hole.

In an embodiment, a hook-and-loop material 1734 may be positioned on thelower side of wings 1730 and the upper part of frame member 1716. Whenthe needle is in the patient and the device is flat against the skin,hook-and-loop material 1732 secures the device in its flat position. Theloop is the simplest of the three options to be able to pull up theentire polygonal structure. Removal may also be accomplished by pullingon a tab or wings 1730.

In an embodiment, there may be a shroud 1900 positioned between hingedportions 1720A-1720D. Shroud 1900 may extend from a low-profile annularring 1900A (FIG. 19) to an extended cylinder 1900C (FIG. 21) so as tocover sharp tip 1712 of needle 1706 when pulled back into a retractedposition. As needle 1706 is being removed from a patient, for example,shroud 1900 will from a more elongated cylinder 1900B (FIG. 20) betweenhinged portions 1720A-1720D until shroud 1900 is deployed to cover sharptip 1712 as extended cylinder 1900C. In other words, the operation ofthe movement of the operator pulling handle 1730 upwardly opens thebellows of shroud 1900 as frame 1716 opens to a greater height. This canbe used instead of, or in addition to, other protection devices.

A needle trap 2200 may be provided at the end of shroud 1900 or otherneedle protection devices. Needle trap 2200 has a rounded tip 2202 thathas a diameter slightly larger than the diameter of needle 1706. Flaps2204 are positioned to abut needle 1706 prior to entrapment withinshroud 1900 or another needle protection device. Flaps 2204 areresilient and biased to move toward one another, for example, to a flatposition when needle 1706 is removed. Flaps 2204 may be positionedrelative to one another such that one overlaps the other preventingneedle 1706 from going back through needle trap 2200.

The material of flaps 2204 can be a number of semi-rigid plastics, whichmay include, for example, PVC and polypropylene, or metal. If plastic isused, the both body and flaps 2204 can be manufactured by injectionmolding techniques in a single process. The thickness and angle of flaps2240 and may be configured to allow bending closer to the inner wall, sothat the needle may be positioned through the end of the needle trap2200 during assembly time. After needle 1706 is withdrawn into shroud1900, the inwardly angled flaps 2204 prevents needle 1706 from goingthrough again.

In another embodiment, and referring to FIGS. 26-29, a flat spring trap2600 has a low-profile configuration with a loaded position and anactivated position to retain needle 1706 subsequent to use. Flat springtrap 2600 may be used in place of needle trap 2200 with shroud 1900, ortrap 2600 may be used with other needle protection devices. For example,a tempered flat wire forming a flat spring 2602 may be bonded at a point2604 to a surface of trap 2600. Away from bonded point 2604, a cover2606 may be in connection with spring 2602. Cover 2606 may have a heightsubstantially equal to spring 2602. Alternatively, cover 2606 may have adifferent height than spring 2602. An orifice 2608 is positioned throughtrap 2600 with a size to accommodate needle 1706. During assembly of aneedle protection device, spring 2602 and cover 2608 are shifted awayfrom orifice 2608 so that needle 1706 is threaded through orifice 2608.When needle 1706 is withdrawn through orifice 2608, spring 2602 movescover 2606 to a position near orifice 2608 so as to prevent needle 1706from again going through orifice 2608. FIG. 26 illustrates needle 1706configured through trap 2600 in a loaded, ready to use position. FIG. 27illustrates cover 2606 in an activated position with needle 1706withdrawn from trap 2600. Trap 2600 is advantageous with a low-profile,an almost flat configuration. For example, spring 2602 may have athickness of 1/32 of an inch. In an embodiment, spring 2602 may be madeout of stainless steel. In another embodiment, spring 2602 may bestamped or otherwise configured from a plastic material. In anembodiment, spring 2602 may be completely flat to have a total height inthe same amount as the thickness of the wire or other material formingthe spring.

In another embodiment, a trap 2600A includes a very small diameterspring 2602A rather than a flat spring. Small diameter spring 2602A maybe about 1/16 of an inch in diameter. Small diameter spring trap 2602Amay be used in place of needle trap 2200, or flat spring trap 2600, withshroud 1900, or with other needle protection devices. For example, aspring 2602 may be bonded at a point 2604A to a portion of trap 2600A.Away from bonded point 2604A, a cover 2606A may be in connection withspring 2602A. An orifice 2608A is positioned through trap 2600 with asize to accommodate needle 1706. During assembly of a needle protectiondevice, spring 2602A and cover 2608A are shifted away from orifice 2608Aso that needle 1706 is threaded through orifice 2608A. When needle 1706is withdrawn through orifice 2608A, spring 2602A moves cover 2606A to aposition near orifice 2608A so as to prevent needle 1706 from againgoing through orifice 2608A. FIG. 28 illustrates needle 1706 configuredthrough trap 2600A in a loaded, ready to use position. FIG. 29illustrates cover 2606A in an activated position with needle 1706withdrawn from trap 2600A. Trap 2600A is advantageous with alow-profile, an almost flat configuration. In an embodiment, spring2602A may be a cylindrical minute spring at least as small as 1/16″ indiameter or smaller such that the diameter of the spring wire isapproximately 20-30 thousands of an inch.

In another embodiment, a sliding door trap 3000 includes a door portion3002 and a housing portion 3004. An exemplary illustration of slidingdoor trap 3000 is shown in FIG. 30. One embodiment of door portion 3002is illustrated in FIG. 31. Across-sectional view of sliding door trap3000 is shown in FIG. 30. An opening through door portion 3002 providesan orifice 3006 for a needle. A spring portion 3008 (of door portion3002 biases against housing portion 3004 so as to move orifice 3006 awayfrom the path of the needle when the needle is removed from orifice3006. Door portion 3002 may include plastic material, metal, or othertypes of material. In an embodiment, door portion 3002 has concentricgrooves to form biasing spring 3008 and an off-centered orifice 3006.During assembly, orifice 3006 is forced into a concentric position byreducing the space between the spiral grooves of spring 3008 to aminimum. When the needle is withdrawn, door portion 3002 realigns backinto a pre-configured natural off-centered position and, thus, theneedle cannot go back through to inadvertently stick a user.

In another embodiment, a needle protection device 3300 includes a needlecovering spring 3302 housed in a recess 3303 within central body portion202. A needle 3304 extends from within needle covering spring 3302 andremains uncovered when needle covering spring 3302 remains within recess3303. In one embodiment, needle trap 2200 (described hereinabove) oranother end portion of spring 3302 may engage an abutment 3506. Torelease spring 3302 after a procedure is completed, abutment 3306 may beactuated to allow needle trap 2200 and a portion of spring 3304 totravel toward the end of the needle. Needle trap 2200 may operate asdescribed above or the spring may operate in another matter, such assimply covering the end of the needle. One way to release spring 3304 isto move portions 3306A and 3306B of abutment 3306 in connection withwings 216, 218 apart from one another. FIGS. 33 and 34 illustrate oneembodiment of device 3300 with abutment 3306 prior to actuation in aloaded configuration. FIGS. 35 and 36 correspond with illustrate device3300 after actuation with spring 3302 actuated to cover needle 3304.

Regarding the polygonal design FIG. 17, one variation of such is amulti-axis polygon which is covered all around. Imagine two triangularpyramids with their bases attached such that the needle is not visiblefrom any side and thus there is no possibility for any finger to beplaced close to the needle at any time during the withdrawal.

Regarding the patient adhesive on the bottom of the polygonal design,such adhesive provides an added level of safety because the clinicianplaces one hand over this layer with the adhesive still on the patientwhile the needle is being withdrawn from the patient and thus the needlereaches the inside of the “accordion” while the clinicians hands arebusy (one with the lower layer and the other with pulling up the toplayer—and thus further reducing the possibility of the needle reachingthe clinician).

Most safety devices require complex mechanisms to trap the needle. Thedevices of the present invention provide simpler, easier to manufacture,and yet modifiable, products that satisfy additional clinicalrequirements beyond safety. These additional requirements include lowerprofile, flexibility, customizability, patient comfort, and scalability.

Lower profile is critical for patients that wear these devices duringprolonged periods of time. Flexibility of the devices is unique as mostother safety devices are made from stiff, mechanically complex plastics.The geometry of these designs can be modified to satisfy specificcriteria, including the need to use this device with a “dual implantedport,” which may be limited by larger foot-print of other existingdevices, and various clinical preferences. Patient comfort is providedin that softer materials are in contact with patient. The ability to usematerials that minimize patient allergenic reactions. As discussedabove, lower profile and smaller foot-print reduce patient discomfort.Scalability is achieved in that various design features may be used inconjunction with one another as desired.

The present disclosure is provided to allow practice of the invention,after the expiration of any patent granted hereon, by those skilled inthe art without undue experimentation, and includes the best modepresently contemplated and the presently preferred embodiment. Nothingin this disclosure is to be taken to limit the scope of the invention,which is susceptible to numerous alterations, equivalents andsubstitutions without departing from the scope and spirit of theinvention.

What is claimed is:
 1. A device for protecting a user from a sharp tipof a winged medical needle, the device comprising: a central bodyportion; a winged medical needle located in the central body portion;the winged medical needle having a first end in fluid connection with adelivery tube, and a second end distal from the central body portionincluding the sharp tip; wherein the winged medical needle issubstantially perpendicular to the delivery tube, a pair of wings, eachwing of the pair of wings having an inner region and an outer region,the inner region of each wing in attachment to the central body portion,the outer region of each wing extending away from the central bodyportion, and the pair of wings being selectively positionable from anopen position to a closed position, where the pair of wings in the openposition are spaced apart from each other to expose the winged medicalneedle to allow placement of the winged medical needle into a treatmentsite and delivery of a medicinal fluid; and wherein the pair of wings inthe closed position cover the winged medical needle to protect againstaccidental needle stick injury from the winged medical needle; amechanical fastener disposed on at least one wing of the pair of wings,the mechanical fastener configured to selectively attach the pair ofwings together in the closed position with the winged medical needlepositioned therebetween to protect against accidental needle stickinjury from the sharp tip of the winged medical needle; the mechanicalfastener including a lip extending along at least a portion of aperimeter of at least one wing of the pair of wings, and a matingportion along a perimeter of at least one other wing of the pair ofwings, and wherein the mating portion and the lip are configured toalign the at least one wing relative to the at least one other wing inthe closed position.
 2. The device of claim 1, wherein each wing, of thepair of wings, is capable of extending generally planarly away from thecentral body portion; the pair of wings disposed in opposition to oneanother with the winged medical needle positioned therebetween.
 3. Thedevice of claim 1, wherein the pair of wings are capable of serving as ahandle by folding back each wing of the pair of wings such that at leasta portion of one wing of the pair of wings is in contact with at least aportion of the other wing of the pair of wings.
 4. The device inaccordance with claim 1, further comprising a handle extending from thecentral body portion.
 5. The device in accordance with claim 4, whereinthe handle extends away from the central body portion in opposition tothe medical needle and in a direction from the second end to the firstend of the medical needle.
 6. The device in accordance with claim 1,wherein the pair of wings have a circular shape.
 7. The device inaccordance with claim 1, wherein the pair of wings include rigidmaterial.
 8. The device in accordance with claim 1, wherein the pair ofwings include semi-rigid material.
 9. The device in accordance withclaim 1, wherein the pair of wings have a rectangular shape.
 10. Thedevice in accordance with claim 1, wherein at least one of the pair ofwings forms a groove therein with a size for housing the medical needleafter the pair of wings are attached to one another.
 11. The device inaccordance with claim 10, further comprising a handle extending from thecentral body portion.
 12. The device in accordance with claim 10,wherein the groove is formed in a single one of the pair of wings.